Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXT — Predicate Candidate Screening
85 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
153 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193397 | ADVIA Centaur® Digoxin assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-16 | 588 | 0 |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics | 2016-04-08 | 147 | 0 |
| K102346 | RANDOX DIGOXIN ASSAY | Randox Laboratories, Ltd. | 2011-10-14 | 421 | 0 |
| K093441 | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), | Siemens Healthcare Diagnostics | 2010-04-07 | 153 | 2 |
| K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODEL | Biokit, S.A. | 2008-12-22 | 80 | 0 |
| K061249 | AXSYM DIGOXIN III | Abbott Laboratories | 2006-06-02 | 29 | 2 |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2003-11-14 | 49 | 0 |
| K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | Seradyn | 2002-10-24 | 41 | 0 |
| K012301 | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 | Diagnostic Products Corp. | 2001-09-19 | 61 | 0 |
| K011302 | RANDOX DIGOXIN | Randox Laboratories, Ltd. | 2001-07-02 | 63 | 0 |
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | Syva Co., Dade Behring, Inc. | 2001-07-02 | 12 | 0 |
| K983323 | DIGOXIN IMMUNOASSAY | Diagnostic Reagents, Inc. | 1998-11-12 | 51 | 0 |
| K983151 | IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT | Beckman Coulter, Inc. | 1998-11-05 | 57 | 0 |
| K982935 | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DR | Beckman Coulter, Inc. | 1998-10-14 | 54 | 0 |
| K980521 | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS | Bayer Corp. | 1998-04-02 | 64 | 0 |
| K973112 | ELECSYS DIGOXIN | Boehringer Mannheim Corp. | 1997-10-10 | 51 | 0 |
| K972794 | DIGOXIN DG-II FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1997-07-31 | 55 | 0 |
| K970883 | CEDIA DIGOXIN II | Boehringer Mannheim Corp. | 1997-05-21 | 72 | 0 |
| K970881 | CEDIA DIGOXIN | Boehringer Mannheim Corp. | 1997-05-14 | 65 | 0 |
| K963062 | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR | Beckman Instruments, Inc. | 1996-12-13 | 128 | 0 |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-12-10 | 77 | 0 |
| K953718 | AXSYM DIGOXIN II | Abbott Laboratories | 1995-09-25 | 47 | 1 |
| K952079 | IMX DIGOXIN | Abbott Laboratories | 1995-07-19 | 77 | 0 |
| K951391 | IL TEST DIGOXIN, PN 181761-00 | Instrumentation Laboratory CO | 1995-06-09 | 74 | 0 |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1995-06-01 | 64 | 0 |
| K951755 | EMIT 2000 DIGOXIN ASSAY | Syva Co. | 1995-06-01 | 45 | 0 |
| K943983 | IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS | Instrumentation Laboratory CO | 1995-04-10 | 307 | 0 |
| K946153 | DIGOXIN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-02-22 | 68 | 0 |
| K944506 | AXSYM DIGOXIN | Abbott Laboratories | 1994-12-19 | 96 | 0 |
| K943500 | EMIT 2000 DIGOXIN ASSAY | Syva Co. | 1994-11-15 | 133 | 0 |
| K940569 | DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET | Sigma Diagnostics, Inc. | 1994-07-13 | 155 | 0 |
| K941255 | CEDIA DIGOXIN PLUS ASSAY | Microgenics Corp. | 1994-06-13 | 91 | 0 |
| K940267 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1994-05-03 | 102 | 0 |
| K934135 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION | Syva Co. | 1994-04-06 | 224 | 0 |
| K934168 | CEDIA DIGOXIN PLUS ASSAY | Microgenics Corp. | 1993-12-29 | 124 | 0 |
| K932732 | ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) | Dupont Medical Products | 1993-11-15 | 161 | 0 |
| K932250 | VIDAS DIGOXIN (DIG) | Biomerieux Vitek, Inc. | 1993-09-10 | 123 | 0 |
| K931123 | DIGOXIN TEST SYSTEM, KXT TX | Syva Co. | 1993-08-05 | 154 | 0 |
| K931213 | ACS DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-06-07 | 89 | 0 |
| K930162 | ACA DIGOXIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1993-03-10 | 56 | 0 |
| K924504 | FAST DIGOXIN TEST SYSTEM | Diatron Corp. | 1993-01-13 | 131 | 0 |
| K925802 | ACCESS DIGOXIN ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-13 | 58 | 1 |
| K924594 | DELFIA DIGOXIN KIT | Wallac OY | 1992-12-17 | 98 | 0 |
| K923853 | CEDIA DIGOXIN PLUS ASSAY | Microgenics Corp. | 1992-09-15 | 50 | 0 |
| K920214 | CEDIA DIGOXIN ASSAY (MODIFICATION) | Microgenics Corp. | 1992-03-02 | 46 | 0 |
| K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-01-17 | 35 | 0 |
| K914151 | IL TEST(TM DIGOXIN | Instrumentation Laboratory CO | 1991-11-29 | 74 | 0 |
| K911941 | CEDIA(R) DIGOXIN R' ASSAY | Microgenics Corp. | 1991-05-15 | 14 | 0 |
| K910642 | CEDIA(R) DIGOXIN SC ASSAY | Microgenics Corp. | 1991-03-21 | 36 | 0 |
| K901547 | OPUS(TM) DIGOXIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-26 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda